BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750001293·7600 LG FF W/AAV 22ID QREL HDG

    ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NEURON MAX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 10, 2022

    ASR UNI FEMORAL IMPL SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·June 3, 2011

    PALMAZ BALLOON-EXPANDABLE STENT

    FDA Adverse Event
    Injury ·NEW JERSEY PLANT·Product code MAF·December 30, 1996

    MEDITECH SYMMETRY BALLOON

    FDA Adverse Event
    Injury ·MEDITECH·Product code LIT·December 30, 1996

    SERIES-A STANDARD PATELLA

    FDA Adverse Event
    Injury ·.·Product code JWH·October 7, 2017

    BIOMET CRUCIATE TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 7, 2017

    VANGUARD POSTERIOR STABILIZED FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 7, 2017

    PALACOS ANTIBIOTIC BONE CEMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LOD·March 27, 2018

    PALACOS ANITBIOTIC BONE CEMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LOD·March 27, 2018

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021